IMIGRAN 10 mg NASAL SPRAY SOLUTION

Introduction

Package Leaflet: Information for the User

Imigran 10 mg Nasal Spray Solution

Sumatriptan

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Imigran and what is it used for
2. What you need to know before you use Imigran
3. How to use Imigran
4. Possible side effects
5. Storing Imigran
6. Contents of the pack and other information

1. What is Imigran and what is it used for

Each Imigran 10 mg nasal spray contains a single doseof sumatriptan, which belongs to a group of medicines called triptans (also known as 5-HT1receptor agonists).

Imigran 10 mg is used to treat migraine headaches.

The symptoms of migraine can be caused by temporary enlargement of blood vessels in the head. It is thought that Imigran 10 mg reduces the enlargement of these blood vessels. This helps to relieve the headache and other symptoms of migraine attacks, such as nausea and vomiting, and sensitivity to light and sound.

2. What you need to know before you use Imigran

Do not use Imigran 10 mg

• if you are allergicto sumatriptan or any of the other ingredients of this medicine (listed in section 6)
• if you have heart problemssuch as narrowing of the arteries (ischaemic heart disease)or chest pain (angina), or have had a heart attack
• if you have circulation problems in your legsthat cause pain when you walk (peripheral vascular disease)
• if you have had a stroke or mini-stroke(also known as a transient ischaemic attack or TIA)
• if you have high blood pressure.You can use Imigran 10 mg if your blood pressure is mildly elevated and is being treated
• if you have severe liver disease
• with other migraine medicines,including those that contain ergotamine, or similar medicines such as methysergide or any triptan/5-HT1 receptor agonist (medicines used to treat migraine)
• with monoamine oxidase inhibitors (MAOIs),or if you have taken these medicines in the last 2 weeks.

If any of these apply to you:

?Tell your doctor, and do not use Imigran 10 mg.

Be careful with Imigran 10 mg

Talk to your doctor or pharmacist before you start using Imigran 10 mg.

If you have any extra risk factors

• if you smoke heavilyor are using nicotine replacement therapy, and especially
• if you are a man over 40 years old,or
• if you are a woman who has started the menopause.

In very rare cases, people have developed serious heart problems after using Imigran 10 mg, even though they had no signs of heart disease before. If any of the above applies to you, this may mean that you have a greater risk of developing heart disease, so:

?Tell your doctor to check your heart functionbefore Imigran 10 mg is prescribed for you.

If you have a history of fits (seizures)

Or if you have other conditions that may make you more likely to have fits – for example, a head injury or alcoholism:

?Tell your doctor to monitor you more closely.

If you have liver or kidney disease

?Tell your doctor to monitor you more closely.

If you are allergic to antibiotics called sulfonamides

If so, you may also be allergic to Imigran 10 mg. If you know you are allergic to antibiotics but are not sure if it is a sulfonamide:

?Tell your doctor or pharmacist before using Imigran 10 mg.

If you are taking antidepressants called SSRIs(Selective Serotonin Reuptake Inhibitors)or SNRIs(Serotonin and Noradrenaline Reuptake Inhibitors)

?Tell your doctor or pharmacist before using Imigran 10 mg. See also Other medicines and Imigran 10 mg.

If you use Imigran 10 mg frequently.

Using Imigran 10 mg too often may make your headaches worse.

?Tell your doctor if this happens to you.Your doctor may recommend that you stop using Imigran 10 mg.

If you feel pain or tightness in your chest after using Imigran 10 mg

These effects may be intense but they usually pass quickly. If they do not pass quickly or become more severe:

?Get medical help immediately.See section 4 of this leaflet for more information on these possible side effects.

Other medicines and Imigran 10 mg

Tell your doctor or pharmacist if you are taking,have recently taken or might take any other medicines. This includes any herbal products or medicines you have bought without a prescription.

Some medicines must not be taken with Imigran 10 mg and others may cause adverse effects if taken with Imigran 10 mg. Tell your doctor if you are taking other medicines,such as:

• Ergotamine, which is also used to treat migraine ,or similar medicines such as methysergide (see section 2 Do not use Imigran 10 mg). Do not use Imigran 10 mg at the same time as these medicines. Stop taking these medicines at least 24 hours before using Imigran 10 mg. Do not take any other medicine that contains ergotamine or ergotamine-like compounds until at least 6 hours after using Imigran 10 mg.
• Other triptans/5-HT1receptor agonists(such as naratriptan, rizatriptan, zolmitriptan), also used to treat migraine(see section 2 Do not use Imigran 10 mg). Do not use Imigran 10 mg at the same time as these medicines. Stop taking these medicines at least 24 hours before using Imigran 10 mg. Do not take another triptan/5-HT1 receptor agonist for at least 24 hours after using Imigran 10 mg.
• SSRIs(Selective Serotonin Reuptake Inhibitors)or SNRIs(Serotonin and Noradrenaline Reuptake Inhibitors)used to treat depression. Using Imigran 10 mg with these medicines can cause serotonin syndrome (a set of symptoms that can include restlessness, confusion, sweating, hallucinations, increased reflexes, muscle spasms, shivering, increased heart rate, and agitation). Tell your doctor immediately if you are affected in this way.
• MAOIs(monoamine oxidase inhibitors)used to treat depression. Do not use Imigran 10 mg if you have taken these medicines in the last 2 weeks.
• St John's Wort(Hypericum perforatum). It is more likely that you will experience side effects if you take herbal remedies containing St John's Wort while you are using Imigran 10 mg.

Pregnancy and breastfeeding

Tell your doctor or pharmacist before using any medicine.

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advicebefore taking this medicine. There is limited information on the safety of Imigran 10 mg in pregnant women, although up to now there is no evidence that it increases the risk of birth defects. Your doctor will weigh up the benefits and risks of using Imigran 10 mg during pregnancy.
• Do not breastfeed for 12 hours after using Imigran 10 mg. If you express breast milk during this time, discard the milk and do not give it to your baby.

Driving and using machines

Migraine symptoms or the medicine may cause you to feel drowsy. If this happens, do not drive or use machines.

3. How to use Imigran

Only use Imigran 10 mg after your migraine headache has started.

Do not use Imigran 10 mg to prevent a migraine attack.

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are not sure, ask your doctor or pharmacist again.

There is a step-by-step guidefor using the nasal spray at the end of the leaflet (see section 6).

How much to use

Adults 18 years and over

• The usual dose for adults aged between 18 and 65 yearsis one spray of Imigran 20 mg into one nostril.

For some people, one spray of Imigran 10 mg into one nostril is sufficient.

Do not use more than two sprays in 24 hours.

Adolescents between 12 and 17 years

• The usual dose for adolescents between 12 and 17 yearsis one spray of Imigran 10 mg into one nostril.

Children under 12 years

• Imigran 10 mg is not recommended forchildren under 12 years.

Elderly (over 65 years of age)

• Imigran 10 mg is not recommended forpeople over 65 years of age.

When to use Imigran 10 mg

• It is best to use Imigran 10 mg as soon as you feel the migraine starting,although you can use it at any time during the attack.

If your symptoms come back

• You can use a second spray of Imigran 10 mg after 2 hours, but do not use more than two sprays in 24 hours.

If the first spray has no effect

• Do not use a second spray,or any other Imigran preparation for the same attack.

If Imigran 10 mg does not relieve your symptoms:

?Talk to your doctor or pharmacist for advice.

If you use more Imigran 10 mg than you should

• Do not use more than two sprays of Imigran 10 mg in 24 hours

Using too much Imigran 10 mg can make you ill. If you have used more than two sprays in 24 hours:

?Contact your doctor for advice.

In case of overdose, contact your doctor or pharmacist or call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount taken.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some of these symptoms may be caused by the migraine itself.

Side effects reported in adults have also been observed in adolescents. These include very rare cases of heart attacks.

Allergic reactions: get medical help immediately

The following side effects have occurred in a very small number of people and their exact frequency is unknown.

• Signs of allergy include rash, hives (itching and rash); wheezing (piping in the chest); swelling of the eyelids, face or lips, collapse.

If you notice any of these symptoms soon after using Imigran 10 mg:

? Never use it again.Contact your doctor immediately.

Very common side effects

(affect more than 1 in 10people)

• Unpleasant taste.

Common side effects

(affect up to 1 in 10people)

• Pain, heaviness, pressure, tightness or pain in the chest, throat or other parts of the body, or unusual sensations, including numbness, tingling and warmth or cold. These effects may be intense but they usually pass quickly.

If these effects continue or get worse(especially chest pain):

?Get urgent medical help. In a small number of people, these symptoms can be caused by heart attacks.

Other common side effects include:

• Irritation or burning sensation in the nose or throat, nosebleeds.
• Nausea or vomiting, although this may be due to the migraine itself.
• Tiredness or drowsiness.
• Dizziness, feeling of weakness or flushing.
• Temporary increase in blood pressure.
• Difficulty breathing.
• Muscle pain.

Very rare side effects

(affect up to 1 in 10,000people)

• Changes in liver function. Tell your doctor or nurse that you are taking Imigran 10 mg if you are going to have a blood test to check your liver function.

Some patients may experience any of the following side effects, but the frequency is unknown

• Seizures/fits, tremors, muscle spasm, stiffness of the neck.
• Visual disturbances such as flickering, reduced vision, double vision, loss of vision, and in some cases even permanent defects (although these may be due to the migraine attack itself).
• Heart problems, in which the heart beats faster, slower or with changes in rhythm, chest pain (angina)or heart attack.
• Pallor, bluish skin and/or pain in the fingers of the hands, fingers of the feet, ears, nose or jaw in response to cold or stress (Raynaud's phenomenon).
• Feeling of weakness (may decrease blood pressure).
• Pain in the lower left side of the abdomen and bloody diarrhea (ischaemic colitis).
• Diarrhea.
• If you have had a recent injury or if you have inflammation (such as rheumatism or inflammation of the colon), you may experience pain or worsening of pain at the site of the injury or inflammation.
• Pain in the joints.
• Anxiety.
• Difficulty swallowing.
• Excessive sweating.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Imigran

Keep this medicine out of the sight and reach of children.

Keep this medicine in the outer packaging (blister) to protect it from light.

Do not store above 30°C and do not freeze.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Imigran 10 mg

The active ingredientis sumatriptan (10 mg).

The other componentsare potassium dihydrogen phosphate, anhydrous disodium phosphate, sulfuric acid, sodium hydroxide, and purified water.

Appearance of the Product and Container Contents

This medication is contained in a pre-loaded spray device and contains sumatriptan in 0.1 ml of colored yellow solution.

Imigran 10 mg is packaged in a box containing individually sealed, single-dose nasal spray devices in blisters. They are available in packs of 1, 2, or 6 pre-loaded nasal spray devices, although not all pack sizes are available in your country. Each spray device contains a dose of Imigran 10 mg.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Manufacturer:

GlaxoSmithKline Manufacturing S.p.A.

Strada Provinciale Asolana, 90

43056 San Polo di Torrile

Parma

Italy

This medication is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

• Imigran nasal spray:Austria, Denmark, Finland, Germany, Italy, Netherlands, Spain, Sweden, and the United Kingdom (Northern Ireland).
• Imitrex nasal spray:Belgium and Luxembourg.

Date of the Last Revision of this Leaflet:October 2021.

Follow the Imigran 10 mg Guide Step by Step

Do not open the blister until you are about to use the spray device.Each spray device is sealed in a blister to keep it safe and clean. If you carry a spray device without the blister, or in an open blister, it may not work properly when you need it.

Each spray device contains only one dose of Imigran 10 mg.

Do not press the plunger too soon or you will lose the dose.

Imigran 10 mg consists of three parts:

How to Use the Nasal Spray Device

1. Remove the nasal spray device fromthe blister packaging only before immediate use.
2. Get into a comfortable position, preferably sitting down.
3. If you feel that your nose is blocked or you have a cold, blow your nose.
4. Hold the nasal spray devicegently with your fingers and thumb as shown in Figure A.

Do not press the blue plunger yet.

1. Close one nostrilby firmly pressing one side of your nose with your finger. It does not matter which nostril you choose.

1. Insert the nasal spray device applicator into the other nostril,up to where it feels comfortable – about 1 cm or half an inch (Figure B).

Breathe out gently through your mouth.

Keep your head upright and close your mouth.

1. Start breathing in gently through your nose.

While breathing in:

Press the blue plunger firmly with your thumb.

The plunger may be a bit stuck, and you may hear a click. Hold your breath while inhaling (Figure C).

1. Remove the nasal spray deviceand remove the finger from the side of your nose.

Keep your head upright for 10-20 seconds,breathing gently in through your nose and out through your mouth. This helps the medication stay in your nose.

You may notice that the inside of your nose feels moist and you may experience a slight characteristic taste after using the nasal spray device – this is normal and will pass soon.

1. Your nasal spray device is now empty.Dispose of it safely and hygienically.

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/